External evaluation of the USAID malaria vaccine develoment project, project number 936-6001

MVDP has been exceptionally successful over the past few years and has become a leader in the rapidly accelerating process of malaria vaccine development, emerging as a unique catalyst and problem-solver by virtue of its combination of expertise, flexibility, and close monitoring of the changing needs in its field. MVDP has been able to fund key targeted areas intended to speed vaccine candidates that would not have been funded by any other entity through the pipeline. MVDP is unique among funding entities in that its staff has a thorough understanding of the whole spectrum of malaria vaccine development issues. No other funder has been able to work as swiftly, or has had the ability to fund relatively small, but essential facets of larger projects. MVDP has assumed a vital role in maintaining a focus on developing vaccines that will protect populations living in endemic regions. Had MVDP never existed, several promising malaria vaccine candidates would either not be nearly as far along in the development process as they are today, or would never have been developed at all. MVDP has been extraordinarily successful in its mission to move vaccines to the clinic and field for proof of principle as soon as possible. Specifically, MVDP support has, directly or indirectly, enabled the work on the Merozoite Surface Protein (MSP1) and the Apical Merozoite Antigen (AMA1) vaccine candidates to move from early preclinical development to clinical trials. MVDP has achieved a very well-balanced portfolio consisting of projects at different phases of malaria vaccine development, and projects involving different kinds of vaccine candidates. Lessons learned include the following: (1) The MVDP, like other public and private entities, needs to be more aggressive in pursuing formal agreements with its partners, in order to ensure that any successful vaccine developed with its funding be made available to populations needing it. (2) Progress in getting effective malaria vaccines to children and pregnant women in developing countries is severely hindered by a lack of resources. (3) Progress is also jeopardized by limited staffing, both of the MVDP and of its partners. The recent re- deployment of several key members of the Walter Reed Army Institute of Research (WRAIR) staff involved in MVDP projects to responsibilities related to a national emergency highlights the importance of being able to be responsive and flexible. This issue is made more acute by the general lack of depth in staffing and resources throughout the malaria vaccine development field. It is strongly recommended that the program be continued and, if at all possible, expanded. One of the most compelling reasons for this is that there are so many potential candidate antigens available for testing today. If this work is not continued, there is a very great risk that progress on important MVDP-supported candidates, such as MSP1 and AMA1, will either be slowed or discontinued for lack of funding and/or for lack of the outside expert guidance provided by MVDP. The importance of preventing death and serious disease from malaria in children and in pregnant women in developing countries cannot be overstated. Malaria not only has a profound effect on health, but also has a major impact on the economic development and political stability of endemic areas. In its 2001 report, the Commission on Macroeconomics and Health of the World Health Organization reported that a small number of conditions, including malaria, are so widespread and debilitating that they can destabilize economies and entire political systems. The impact of malaria has grown in recent years, despite longstanding treatment and prevention programs. There is a consensus among experts that, ultimately, the most effective way to control malaria is to develop a vaccine that is effective in vulnerable populations, particularly children and pregnant women in endemic areas. In addition, it is predicted that in the long run, a vaccine will be much more cost-effective than reliance on current control measures.